Kornimate/medical-research-clean huggingface dataset:
medication adherence and non-adherence in adults with rare disease

Conditions: Cystic Fibrosis; Hemophilia A; Hemophilia B; Idiopathic Pulmonary Fibrosis; Myasthenia Gravis; Sickle Cell Disease

Summary: the purpose of this study is to use the medication adherence reasons scale (mar-scale) to determine the extent of non-adherence to specific medications indicated to treat cystic fibrosis, hemophilia (a or b), idiopathic pulmonary fibrosis, myasthenia gravis, and sickle cell disease, and to identify the top patient-reported reasons for non-adherence. internal reliability of the mar-scale will also be assessed in each condition.


Eligibility criteria:
inclusion criteria: * have a confirmed (self-reported) diagnosis by a doctor or other licensed healthcare professional of one of the following conditions: * cystic fibrosis * hemophilia (a or b) * idiopathic pulmonary fibrosis * myasthenia gravis * sickle cell disease * have access to the internet * are aged 18 years or above * are comfortable reading and answering questions in english * have an active prescription for at least one medication indicated to treat the relevant condition (self-reported) * nb: individuals will be eligible even if the prescription has not been dispensed (filled) yet, and also if they have the medication(s), but are not actually taking it/them are able and willing to provide consent electronically through the my.raremark.com platform exclusion criteria: * there are no exclusion criteria. any member of a raremark community will be able to take part in this study if they meet the inclusion criteria and can provide their informed consent.

Keywords: adherence mar-scale rare disease observational
high-dose,pulsatile erlotinib/gefitinib for advanced nsclc patients after failure of standard dose egfr-tkis

Conditions: Self Efficacy; Drug Toxicity

Summary: the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile erlotinib/gefitinib in advanced non small cell lung cancer (nsclc) patients after failure of standard dose egfr-tkis（epidermal growth factor receptor-tyrosine kinase inhibitors）

to evaluate the efficacy and safety by treating the advanced non small cell lung cancer (nsclc) patients who have failure of standard dose egfr-tkis(erlotinib or gefitinib ) with high-dose, pulsatile erlotinib(450mg every 3 days) or gefitinib (1000mg every 4 days)

Eligibility criteria:
inclusion criteria: * 1. nsclc patients were confirmed by histology or cytology 2. patients were ever treated with standard dose egfr-tkis(erlotinib or gefitinib )on which he/she achieved complete remission/partial remission,or maintained stable disease for 4 months.disease progression at present (accord to recistv1.1 criteria） 3.at least one target lesion that has not previously been radiated and is measurable according to recist v1.1; 4.have an ecog ps of 0-2 5.at least 8 weeks of expected survival time 6.have no serious cardiovascular,hepatobiliary or renal disorders 7.provision of a voluntarily given, personally signed and dated, written informed consent document 8.must be in accordance with the following laboratory biochemical data: hgb≥80g/l，wbc≥3.0×10\^9/l，anc≥1.0×10\^9/l， plt≥80×10\^9/l renal function：scr≤uln liver function： if no hepatic metastases:ast/alt≤2.5uln if hepatic metastases:ast/alt≤5uln exclusion criteria: * if the subject meet any of the following exclusion criteria ,he/she is no eligible to participate in this study 1. have chronic toxicity reaction(above grade 2) and not recovered( hair loss not include) 2. have appeared skin rashes or diarrhea(above grade 3),or have any reason lead to decrement during standard dose egfr-tkis treatment 3. female subjects who are in pregnancy or lactation，or of childbearing age but don't take any contraceptive measures 4. current enrollment in another therapeutic clinical study 5. have any symptoms of brain metastases or leptomeningeal metastases 6. subjects will not be eligible if they have history of prior malignancy in past 5 years 7. any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this study or known drug abuse/alcohol abuse.

Keywords: advanced non-small cell lung cancer high-dose pulsatile egfr-tkis
hypertension management using telemonitoring

Conditions: Hypertension

Summary: this is a prospective study evaluating the feasibility and safety of remote hypertension management using a central telemonitoring program among patients with elevated blood pressure (bp) at the university of mississippi medical center (ummc).

patients with elevated bp, identified by the electronic medical record, will be recruited for study enrollment. patients will be mailed a telemonitoring kit including an electronic tablet equipped with a wireless bp cuff that transmits measurements directly to the ummc electronic medical record and monitored by the ummc center for telehealth. patients will participate in a 6 month intervention period during which they will transmit daily bp recordings with regular contact by a telehealth nurse coordinator who will provide education and encourage healthy lifestyle habits. every 2 weeks bp medications will be adjusted according to an evidence-based treatment algorithm managed by the center for telehealth pharmacist using a standardized physician-approved protocol. data analysis will track metrics of study enrollment, study completion, safety, therapeutic intensification, and bp change from baseline.

Eligibility criteria:
inclusion criteria: 1. age greater than 18 years 2. patient of ummc clinician approving the study 3. at least 2 clinic encounters in the past 12 months with systolic bp ≥ 140 mmhg and/or diastolic bp ≥ 90 mmhg exclusion criteria: 1. stage 4 or 5 chronic kidney disease 2. systolic heart failure (lvef \<50%) or major cardiovascular event (mi, stroke) within 3 months 3. resistant hypertension (prescribed 3 or more antihypertensive medications at target doses) or known secondary cause of hypertension 4. pregnancy or inability/unwillingness to use birth control for women of child-bearing potential 5. institutionalized, dementia, limited life expectancy, uncontrolled mental illness, substance abuse, or other conditions that would prohibit ability to perform regular home bp monitoring

Keywords: hypertension telemedicine
robotic assisted surgery for treatment of gynecological diseases: pilot study

Conditions: Adnexal Diseases; Uterine Diseases

Summary: this is a prospective, single-center clinical trial. one hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative telelap alf-x endoscopic robotic surgical system with the primary objective of assessing the feasibility, efficacy and safety of this approach.

the study proposed comprises a prospective, single-center clinical trial (catholic university of the sacred heart of rome, a. gemelli university polyclinic). one hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative telelap alf-x endoscopic robotic surgical system with the primary objective of assessing the feasibility, efficacy and safety of this approach. post-operative pain will be reported by the patients through a visual analog scale (vas). it will be assessed at 2, 4 and 12 and 24 hours after the procedure. at the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the standard laparoscopic approach to multiple access and/or to a laparotomic approach will be analyzed in order to arrive at the feasibility and efficacy of robotic assisted treatment.

Eligibility criteria:
patient inclusion criteria: * age ≥ 18 years old * sign the informed consent form * bmi ≤ 40 * a.s.a. class \< iii or iv disease inclusion criteria: * ovarian cyst (enucleation/oophorectomy) * prophylactic bilateral oophorectomy * ectopic pregnancy (salpingotomy/salpingectomy) * tubal inflammatory disease (salpingotomy/salpingectomy) * infertility and sterility (treatment of endometriosis, chromo-salpingography, etc.) * benign uterine disease (fibromatosis, adenomyosis) * endometrial hyperplasia * stage ia g1-2 endometrial tumors * precancerous lesions of the uterine cervix * stage ia uterine cervical tumors * pelvic endometriosis patient exclusion criteria: * pregnancy * liver disease * coagulation disorders * patient internal or anatomical criteria that preclude a laparoscopic approach
observational study to evaluate ldl-c lowering effect of ezetimibe (0653-070)

Conditions: Hypercholesterolemia

Summary: to evaluate the ldl-c lowering in south african patients with primary hypercholesterolaemia after the addition of ezetimibe 10mg /day to ongoing therapy with a statin.


Eligibility criteria:
inclusion criteria: * men or women \>18 and \<80 years of age * patients receiving statin therapy for a minimum period of 6 weeks prior to visit 1 * female patients receiving hormone therapy (including hormone replacement therapy, any estrogen antagonist/agonist, or oral contraceptives) if maintained on a stable dose and regimen for at least 8 weeks prior to visit 1 and if willing to continue the same regimen throughout the study * liver enzyme levels less than or equal to 1.5 times the upper limit of normal with no active liver disease and cpk less than or equal to 1.5 times upper limit of normal at visit 1 exclusion criteria: * cardiovascular medications, such as beta-blockers, calcium-channel blockers, angiotensin ii receptor antagonists or anticoagulants (i.e., warfarin) unless treated with a stable regimen for at least 6 weeks prior to randomization and patient agrees to remain on constant regimen for the duration of the study * patients on amiodarone hydrochloride will also be excluded * general weight less than 50% of ideal body weight according to the 1983 metropolitan height and weight tables or weighing less than 100 lbs (45 kg) * hypersensitivity to hmg-coa reductase inhibitors * patient has congestive heart failure defined by nyha class iii or iv, uncontrolled cardiac arrhythmias, unstable angina pectoris, or myocardial infarction; coronary artery bypass surgery, or angioplasty within 3 months of visit 1 * taking lipid-lowering agents including fish oils, cholestin, bile-acid sequestrants and niacin (grater than 200 mg/day) taken within 6 weeks and fibrates taken within 8 weeks prior to visit 1 * taking medications that are potent inhibitors of cyp3a4, including cyclosporine, systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, verapamil and protease inhibitors * consumption of greater than 250 ml of grapefruit juice/day * taking oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and on a stable regimen for at least 6 weeks prior to visit 1 * treatment with psyllium, other fiber-based laxatives, and/or otc therapies known to affect serum lipid levels, phytosterol margarines, unless treated with a stable regimen for at least 6 weeks prior to visit 1 and patient agrees to remain on constant regimen for the duration of the study * women who are pregnant or lactating
pcos, therapy and markers of cardiovascular risk

Conditions: PCOS

Summary: in addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (pcos) is also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn lead to the development of diabetes, hypertension, atherosclerosis and coronary heart disease. serum markers of inflammation are being increasingly recognized as predictors of atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been recently proposed to play a role in the pathogenesis of metabolic syndrome and type 2 diabetes mellitus. therefore, the aim of the present study is to evaluate the effects of commonly used non-pharmacologic (diet and lifestyle change) and pharmacologic (oral contraceptives, metformin, anti-androgens) treatment strategies on classical and surrogate cardiovascular risk markers in women with pcos. the study hypothesis is that some of the commonly used therapies of women with pcos may have more favorable effects on classical and surrogate markers of cardiovascular risk then others or some of them may even confer a higher risk of cardiovascular events


Eligibility criteria:
inclusion criteria: * pcos exclusion criteria: * diabetes * pregnancy * contraindications to oral contraceptives

Keywords: pcos metformin oral contraception cyproterone acetate
whole-body hyperthermia for mild to moderate depressive disorder

Conditions: Depression, Unipolar

Summary: the primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment. secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.


Eligibility criteria:
inclusion criteria: * unipolar depression (diagnosed according to the dsm-iv) * mild depression: 8-16 points on the hamd-17 or moderate depression: 17-23 points on the hamd-17 exclusion criteria: * current psychotherapy * antidepressant drug treatment in the last 4 weeks before study inclusion * participants who did not respond to prior antidepressant drug treatment, electroconvulsive therapy, or sleep deprivation (therapy-resistant depression) * acute suicidality * prior treatment with whole-body hyperthermia * contraindications to hyperthermia treatment: acute or feverish infections, severe cardiovascular diseases (e.g. angina pectoris, heart failure, thrombosis, bleeding diathesis), severe gastrointestinal diseases (e.g. renal insufficiency, hepatitis, liver cirrhosis, peptic ulcer), severe neurological diseases (e.g. epilepsy, multiple sclerosis, cerebrovascular malformations or brain tumors), severe endocrine diseases (e.g. hyperthyroidism), or oncological diseases without remission * participants taking anti-inflammatory or immunosuppressive drugs * participants with severe psychiatric comorbidities (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, dementia, adhd, obsessive-compulsive disorder, ptsd, alcohol or drug addiction) * women during pregnancy and breastfeeding * lack of ability to consent

Keywords: depression hyperthermia randomized controlled trial
an observational study to evaluate effectiveness and safety of amosartan q tablet

Conditions: Hypertension; Dyslipidemia

Summary: this study was to evaluate the therapeutic effect and safety of amosartan q tablet administration in adult patients with hypertension and dyslipidemia. during the routine medical visit, amosartan q tablets were administered to patients in need of blood pressure/ldl-c control according to the investigator's judgment. in this study, effectiveness and safety information of treatment of amosartan q tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data. as this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

this study was a multicenter, prospective, non-interventional, observational study of factors affecting blood pressure and blood lipids after treatment with amosartan q tablet in hypertension patients with dyslipidemia. data was collected from patients receiving routine treatment at hospitals in south korea. each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of amosartan q tablet. this study approved by the institutions' irbs and was conducted in compliance with clinical research ethics regulations.

Eligibility criteria:
inclusion criteria: * patients with hypertension and dyslipidemia * those who have already decided to administer amosartan q tablet under the medical judgment of the researcher * those who voluntarily decided to participate in this study and consented in writing to the consent form exclusion criteria: * patients for whom use of amosartan q tablet is prohibited

Keywords: amosartan hypertension dyslipidemia observational
could ki-67 be used as a diagnostic or prognostic marker in hemato-oncological diagnostics?

Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia; Myelodysplastic Syndrome/Neoplasm

Summary: ki-67 is used as a marker for determination of the proliferative activity in solid tumors. the use within hemato-oncological malignancies is limited. this is related to limited technical possibilities of flow cytometry in the past. meanwhile, flow cytometry in hemato-oncological malignancies has progressed to assessment of 8 colors and makes it possible to add ki-67 as an additional marker to the 8-color panels. adding ki-67 to these panels could lead to improved diagnosis and prediction of therapy response for a number of hemato-oncological malignancies.


Eligibility criteria:
inclusion criteria: * mds and aml patients exclusion criteria: * ongoing radio- and/or chemotherapy

Keywords: ki-67
use of avanta metacarpophalangeal (mcp) joint implant finger prosthesis, humanitarian use device

Conditions: Arthroplasty of the MCP Joint

Summary: the purpose of this study is to allow patients to undergo surgery with the sr™ mcp (metacarpophalangeal) implants for finger arthritis. this is not a research study, but rather, a requirement by the fda for humanitarian use of device.

the purpose of this irb approved study is to allow patients to undergo surgery with the sr™ mcp (metacarpophalangeal) implants. this is not a research study, but rather, a requirement by the fda for humanitarian use of device. use of the sr™ mcp is approved for humanitarian use by the fda when either the patient is in need of a revision of failed mcp prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic mcp joint.

Eligibility criteria:
inclusion criteria: * patient is in need of a revision of failed mcp prosthesis(es) * patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic mcp joint exclusion criteria: * patient is not in need of a revision of a failed mcp prothesis(es) * patient is eligible to use an alternative implant

Keywords: osteo-arthritis post traumatic arthritis
a study of adebrelimab in combination with chemo with or without bevacizumab neoadjuvant therapy for resectable nsclc

Conditions: Resectable Lung Non-Small Cell Carcinoma

Summary: this is a prospective, multicenter, randomized, uncontrolled phase ii study to assess the efficacy and safety of adebrelimab in combination with chemotherapy with or without bevacizumab for the treatment of resectable stage ii-iiib (t3n2) nsq-nsclc and to explore biomarkers associated with efficacy.

neoadjuvant therapy with experimental treatment followed by surgery.

Eligibility criteria:
inclusion criteria: * resectable nsq nsclc * age 18-65 years * male or female * ecog 0-1 * subjects have not received surgery, chemotherapy, radiotherapy and biological treatment of treatment-naive non-squamous non-small cell lung cancer * subjects must have adequate pulmonary function for the intended pneumonectomy; exclusion criteria: * sclc or sq nsclc * previously used anti-pd1, anti-pdl1, anti-ctla4 antibodies, etc. * patients who have previously used anti-angiogenic drugs; * allergic to any component of the study drug or chemotherapy drugs * patients with any severe and or uncontrolled disease
role of tissue c4d in differentiation between acut e rejection and hcv recurrence after liver transplantation

Conditions: Liver Disease

Summary: assessment of the role of tissue c4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and hepatitis c (hcv) recurrence in recipients post living donor liver transplantation (ldlt) .as each condition require different treatment

role of tissue c4d assessment by immunohistchemistry in liver biopsy in differentiation between recurrent hepatitis c and rejection after liver transplantation.pathological examination may be sometimes confusing between the rejection and recurrent hepatitis c

Eligibility criteria:
inclusion criteria: * patients transplanted for hcv related disease that are presented with elevated liver enzyme and/or hyperbilirubinemia and normal abdominal doppler ultrasound and magnetic resonance cholangiography (mrcp). exclusion criteria: * evidence of other causes of elevated liver enzyme and/or hyperbilirubinemia as abnormal abdominal doppler ultrasound and/or magnetic resonance cholangiography mrcp findings.

Keywords: hepatitis c recurrence rejection liver transplantation liver biopsy
pcc and fibrinogen compared with ffp in pph

Conditions: Postpartum Haemorrhage

Summary: the purpose of the study is to find out if the regimen of prothrombin complex concentrate (pcc) together with fibrinogen concentrate is as efficient as fresh frozen plasma (ffp) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (pph). the original protocol included the use of hes and the recruitment of patients was postponed while waiting the final decision by ema. all hes solutions were abandoned at our institution in september and an amendment was made to change the protocol. hes solution are replaced by the use of hyperoncotic (20%) albumin.

forty patients are randomized to receive either pcc and fibrinogen concentrate (pcc group) or ffp (and fibrinogen if needed) (ffp group), 20 patients in each group. patients in the pcc group receive 15 iu/kg of pcc concentrate and 2 g of fibrinogen concentrate. patients in the ffp group receive 4 units of ffp. in both groups, additional fibrinogen is administered (if needed) to increase the baseline fibtem-mcf (at 5 min) to the target of 15 mm. baseline blood samples will be drawn at study inclusion when the (on-going) blood loss exceeds 1500 ml. the next samples will be drawn at 45 min (or immediately after the administration of the study drug if later). otherwise, the management protocol strictly follows the local pph guideline. the primary endpoint is the amount of blood loss within the first 6 and 24 hours after delivery. secondary endpoints include the difference/similarity in the laboratory determinations (ia coagulation screen, pfa-100, cat and rotem).

Eligibility criteria:
inclusion criteria: women who have delivered vaginally or by caesarean section with a pph of 2000 ml (the amount of blood loss: in addition to the suctioned blood, sponges, wraps, swabs, etc. are carefully weighed) exclusion criteria: women with a history of bleeding tendency or hepatic or renal insufficiency, or pph exceeding 3000 ml because in that case the initial need for fibrinogen may be even more